BEUDAMED
    FDA Adverse Event Injury Summary report: N

    FIBERGRAFT BG MATRIX

    MDR report key: 17988260 · Received October 23, 2023

    Report

    Report Number
    3011015097-2023-00027
    Event Type
    Injury
    Date Received
    October 23, 2023
    Report Date
    October 19, 2023
    Manufacturer
    PROSIDYAN, INC.
    Product Code
    MQV
    PMA / PMN Number
    K180080
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED TO THE MANUFACTURER ON SEPTEMBER 25, 2023 THAT A PATIENT FROM A RETROSPECTIVE CLINICAL STUDY EXPERIENCED IMPLANT DISPLACEMENT, INFECTION, TENDERNESS, AND HEMATOMA REQUIRING SCREW REPLACEMENT AT 12 MONTHS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2128894 FIBERGRAFT BG MATRIX RESORBABLE CALCIUM SALT BONE VOID FILLER DEVICE MQV PROSIDYAN, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Female Other| R